Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02854202
Status:
UNKNOWN
Last Update Posted:
2016-08-03
First Post:
2016-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Protein Breakfast on Postprandial Glycemia in T2D (PBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2016-07-31', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': '3 month', 'description': 'Overall postprandial glycemia after breakfast, lunch and dinner'}], 'secondaryOutcomes': [{'measure': 'Satiety', 'timeFrame': '3 month', 'description': 'Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale.'}, {'measure': 'Change in body weight', 'timeFrame': '3 month', 'description': 'Body weight will be assessed every every two weeks during 3 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).', 'detailedDescription': 'It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants: from 30 to 72 years of age\n2. BMI: 26 to 34 kg/m2)\n3. Diabetes criteria\n4. HbA1C: 7-9 % or\n5. Habitually eat breakfast\n6. Only naïve or treated with metformin.\n7. Not dieting and no change in body weight \\>10 lb = 4.5 kg within the last 3 months\n8. Normal liver, kidney and thyroid function.\n\nExclusion Criteria:\n\n1. Type 1 Diabetes\n2. Anemia (Hg \\> 10 g/dL)\n3. Serum creatinine level \\< 1.5 mg/dl\n4. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.\n5. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate\n6. Infectious disease\n7. Pregnant women or lactating\n8. Known hypersensitivity to milk components\n9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.'}, 'identificationModule': {'nctId': 'NCT02854202', 'acronym': 'PBD', 'briefTitle': 'High Protein Breakfast on Postprandial Glycemia in T2D (PBD)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas Caracas'}, 'officialTitle': 'Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'HCCBI 017-2008-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1-Whey protein', 'description': 'In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey', 'interventionNames': ['Other: Arm1: Whey protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 Breakfast- other proteins', 'description': 'In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast', 'interventionNames': ['Other: Arm 2 Breakfast- other proteins']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3 Breakfast- low protein', 'description': 'In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast', 'interventionNames': ['Other: Arm 3 Breakfast- low protein']}], 'interventions': [{'name': 'Arm1: Whey protein', 'type': 'OTHER', 'otherNames': ['WB'], 'description': 'Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast', 'armGroupLabels': ['Arm 1-Whey protein']}, {'name': 'Arm 2 Breakfast- other proteins', 'type': 'OTHER', 'otherNames': ['PB'], 'description': 'Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast', 'armGroupLabels': ['Arm 2 Breakfast- other proteins']}, {'name': 'Arm 3 Breakfast- low protein', 'type': 'OTHER', 'otherNames': ['LP'], 'description': "Arm 3: Low protein' :The participants will consume 22 g protein at breakfast", 'armGroupLabels': ['Arm 3 Breakfast- low protein']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniela Jakubowicz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wolfson Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas Caracas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daniela Jakubowicz, MD', 'investigatorAffiliation': 'Hospital de Clinicas Caracas'}}}}